Recall Z-1939-2018 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.
| Date | Apr 20, 2018 |
| Status | Terminated |
| Reason | There is a potential for a software issue that may cause the need for necessary patient rescans. |
| Root cause | Software design |
| Action | The firm, Siemens Healthineers, sent an "Customer Safety Advisory Notices" letter dated 4/20/2018 beginning on 4/20/18 to its customers. The letter described the product, problem and actions to be taken. The letters provided the following information to customers: How can the operator help to avoid a potential risk of the system? To avoid an unnecessary additional X-ray dose to patients please observe the following instructions: Topic 1: If a reconstruction cannot be started after an examination, please reboot the system and repeat the aborted reconstruction. If the error persists, please c |
| Quantity | 4 units in US |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AR, CA, CT, FL, GA, IL, IN, KS, KY, MO, ND, NY, OH, OK, SD, TN, TX, and VA; and countries of: Algeria, Australia, Austria, Bangladesh, Bolivia, Bosnia Herzog., Brazil, Cambodia, Chile, China, Columbia, Costa Rica, Germany, Greece, India, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163296 | SOMATOM go.Up, SOMATOM go.Now Siemens Medical Solutions USA, Inc., Mar 21, 2017 |